Nursing Management of Gastrointestinal Adverse Events Associated With Delayed-Release Dimethyl Fumarate: A Global Delphi Approach.

BACKGROUND: Gastrointestinal (GI) adverse events (AEs) are commonly encountered with delayed-release dimethyl fumarate (DMF), an approved treatment for relapsing multiple sclerosis (MS). METHODS: Two hundred thirty-nine MS nurses from 7 countries were asked to complete a 2-round Delphi survey developed by a 7-member steering committee. Questions pertained to approaches for mitigating DMF-associated GI AEs. RESULTS: Ninety-six percent of nurses followed the label recommendation for DMF dose titration in round 1, but 77% titrated the DMF dose more slowly than recommended in round 2. Although 86% of nurses advised persons with relapsing forms of MS (PWMS) to take DMF with food, patients were not routinely informed of appropriate types of food to take with DMF. Most nurses recommended both pharmacologic and nonpharmacologic symptomatic therapies for PWMS who experienced GI AEs on DMF. Pharmacologic and nonpharmacologic symptomatic therapies were regarded as equally effective at keeping PWMS on DMF. In round 2, 58% of nurses stated that less than 10% of PWMS who temporarily discontinued DMF went on to permanently discontinue treatment. Sixty-six percent of nurses stated that less than 10% of PWMS permanently discontinued DMF because of GI AEs in the first 6 months of treatment in round 1. Most nurses agreed that patient education on potential DMF-associated GI AEs contributes to adherence. CONCLUSION: This first real-world nurse-focused assessment of approaches to caring for PWMS with DMF-associated GI AEs suggests that, with implementation of slow dose titration, symptomatic therapies, and educational consultations, most PWMS can remain on DMF and, when necessary after temporary discontinuation, successfully restart DMF.

"Taming the Beast": Exploring the Lived Experience of Relapsing Remitting Multiple Sclerosis Using a Life History Approach.

BACKGROUND AND PURPOSE: The aim of this study was to gain insights and understanding into the lived experience of relapsing remitting multiple sclerosis (RRMS) in order to better inform patient-centerd nursing and healthcare. METHODS: This qualitative study used life history methodology, a form of focused ethnography, to explore the life history of 13 study participants living with RRMS. Semi-structured interviews were transcribed and analysed using thematic analysis. FINDINGS: A total of eight key themes emerged, explaining the journey of living with RRMS. Commencing with "Piecing Together the Puzzle" of symptoms at the beginning of the RRMS journey, followed by "(Re)defining ME now that I have RRMS," "Battling the Demons," the experiences of "Surplus Suffering," negotiating "High Invisibility," gaining control by "Taming the Beast," learning "The DMT Dance," and ultimately "Holding Hands with Hope," expressing hope and practising purposeful positivity. IMPLICATIONS FOR PRACTICE: The eight key themes of living with RRMS were reflective of the ebbs and flows of life. By gaining these insights into the world of people living with RRMS, it is anticipated that clinical nursing care and quality of life for people living with this chronic neurological disease may be improved.

Predictors of burden and depression among caregivers of relapsing-remitting MS patients in Spain: MS Feeling study.

AIM: To assess potential predictors for burden and depression among caregivers of relapsing-remitting multiple sclerosis patients in Spain. Family functioning and social support were also assessed. PATIENTS & METHODS: Multicenter and cross-sectional study in relapsing-remitting multiple sclerosis adult patients and their respective informal caregivers (n = 180). Assessment performed: Zarit Scale (Burden), Center for Epidemiologic Studies Depression-7 Scale (depression), Family APGAR (Adaptation, Partnership, Growth, Affection, Resolve) Questionnaire (family functioning) and Duke UNC-11 Functional Social Support Questionnaire (social support). Multivariate logistic regression analysis assessed burden and depression predictors among caregivers. RESULTS: Caregivers suffered burden (19.4%) and depression (20.6%) and perceived poor social support (9.4%) and family dysfunction (10.6%). Burden predictors were patient's degree of disability, caregiver time and number of medications administered to patient. Depression predictors were patient's age and daily caregiving time. CONCLUSION: The factors reported here could help clinicians to identify caregiver groups particularly at risk of burden and depression for timely intervention.

Relation of Demographics and Reported Symptoms and Medication Use in Persons with Multiple Sclerosis.

A study using a cross-sectional descriptive design examined symptoms, race, sex, and use of disease-modifying therapies (DMT) in persons with relapsing remitting multiple sclerosis. Significant differences in symptoms and DMT use were found among women, men, and African Americans.

A patient care program for adjusting the autoinjector needle depth according to subcutaneous tissue thickness in patients with multiple sclerosis receiving subcutaneous injections of glatiramer acetate.

BACKGROUND: The perceived pain on injection site caused by subcutaneous (SC) self-injection may negatively affect acceptance and adherence to treatment in patients with multiple sclerosis (MS). Pain on injection may be caused by inaccurate injection technique, inadequate needle length adjustment, or repeated use of the same injection body area. However, information is lacking concerning the optimal needle depth to minimize the injection pain. OBJECTIVE: The purpose of this program was to characterize the perceived injection-site pain associated with the use of various injection depths of the autoinjector of glatiramer acetate (GA) based on SC tissue thickness (SCT) of the injection site. METHODS: This was a pilot program performed by MS-specialized nurses in patients with MS new to GA. Patients were trained by MS nurses on the preparation and administration of SC injection and on an eight-site rotation (left and right arms, thighs, abdomen, and upper quadrant of the buttock). The needle length setting was selected based on SCT measures as follows: 4 or 6 mm for SCT < 25 mm, 6 or 8 mm for SCT between 25 and 50 mm, and 8 or 10 mm for SCT > 50 mm. Injection pain was rated using a visual analog scale (VAS) at 5- and 40-minute postinjection and during two 24-day treatment periods. RESULTS: Thirty-eight patients with MS were evaluated. The mean SCT ranged from 15.5 mm in the upper outer quadrant of the buttocks to 29.2 mm in the thighs. The mean perceived pain on injection was below 3 for all the injection sites, at both time points (5 and 40 minutes) and during both 24-day evaluation periods. The mean VAS scores were significantly greater after 5 minutes of injection compared with that reported 40-minute postinjection during both 24-day treatment periods and for all the injection areas. Mean VAS measures at 5- and 40-minute postinjection significantly decreased during the second 24-day treatment period with respect to that reported during the first 24 SC injections for all injection sites. CONCLUSIONS: Our findings suggest that the adjustment of injection depth of SC GA autoinjector according to SCT of body injection areas is suitable to maintain a low degree of postinjection pain. Moreover, our results also may indicate that the use of needle lengths of 6 mm or shorter is appropriate with regard to injection pain for adult patients with MS with SCT < 50 mm.

Redefining self: patients' decision making about treatment for multiple sclerosis.

The treatment of multiple sclerosis (MS) has become possible with the advent of disease-modifying therapies, but little is known about patients' experiences when faced with a complex array of treatment options. The purpose of this phenomenological study was to explore the lived experience of making a first decision about treatment with disease-modifying therapies for relapsing-remitting MS. Nine participants shared their perspectives on negotiating the decision to accept, refuse, or delay treatment. All individuals described a core theme in which decision making about treatment was part of a process of coming to a "redefined self." This core theme included reflections about self-image, quality of life, goals, and being a person with MS. Six common themes supporting this core theme were (a) weighing and deciding what's important, (b) acknowledging the illness as part of oneself, (c) playing the mental game, (d) seeking credible resources, (e) evaluating symptoms and fit with quality of life, and (f) managing the roles and involvement of family. The findings of this study provide a greater understanding about the experience of making a therapeutic choice for those with MS and offer insights for nurses when supporting patients faced with options about treatment.

Pegylated interferons: a nurses' review of a novel multiple sclerosis therapy.

Most multiple sclerosis (MS) therapies are injectable drugs, and the frequency of injections has been shown to be inversely proportional to overall compliance. One method of improving therapeutic compliance and thus clinical outcomes is to develop medications that require less frequent dosing. One of the most promising modification techniques to extend the bioavailability of a drug is poly(ethylene glycol) conjugation (pegylation), which increases the size of a molecule by attaching polyethylene glycol moieties to the parent compound, resulting in slower clearance and metabolism. This approach has been used to improve the efficacy of a number of therapeutic molecules, including interferons. Peginterferon beta-1a, a pegylated form of interferon beta-1a, is currently in phase III clinical trials for relapsing MS and has the potential to improve patient compliance by reducing the number of injections while maintaining clinical efficacy. The role of nurses in educating patients about the effective use of this new MS therapy is discussed.

Assessing the role of patient support services on adherence rates in patients using glatiramer acetate for relapsing-remitting multiple sclerosis.

OBJECTIVE: To assess predictors of achievement of 80% Medication Possession Ratio (MPR) in patients receiving manufacturer-provided self-management services for relapsing-remitting multiple sclerosis (RRMS) patients taking glatiramer acetate (Copaxone). METHODS: De-identified patient records were selected for study inclusion if patients had been (1) continuously enrolled in one or more aspects of the self-management program for a minimum of 24 months and had adherence measured by MPR between the values of zero and one. Baseline patient univariate measures were assessed using chi-squared statistics for categorical variables and Analysis of Variance (ANOVA) for continuous variables. Bivariate logistic regression models were used to assess predictors of 80% MPR. RESULTS: A total of 5825 patients met the study inclusion criteria. About 70% of patients received manufacturer-provided injection training and 75% were eligible for, and utilized, copayment assistance; 74.3% of patients accessing sponsor provided support achieved a desired MPR of greater than or equal to 80%. Patients were 40% more likely to reach goal if injection training was provided by the manufacturer (OR = 1.435; 95% CI = 1.258-1.636) and were 30.6% more likely to achieve goal when eligible patients utilized copayment assistance programs (OR = 1.306; 95% CI = 1.109-1.570). Patients reinitiating treatment were at risk of lower adherence rates (OR = 0.605; CI = 0.476-0.769) compared to those who were new to therapy. CONCLUSIONS: Manufacturer-provided patient support programs improve adherence to glatiramer acetate therapy.

The use of focus groups to characterize symptoms in persons with multiple sclerosis.

Multiple sclerosis is a chronic neurological disease with a myriad of symptoms. Because most work has been quantitative, it is important to capture symptoms as described by patients who experience them, using a qualitative approach. The purpose of our study was to describe and identify symptoms, with emphasis on co-occurrence, using focus groups. Three focus groups were conducted (N = 16) with relapsing-remitting multiple sclerosis patients. Common symptoms, described as both singular and co-occurring, were problems with balance, cognition, vision, and heat intolerance. These findings augment past characterizations of symptoms experienced in persons with relapsing-remitting multiple sclerosis and provide evidence for future studies.

Symptom clusters in women with relapsing-remitting multiple sclerosis.

The purpose of this secondary analysis was to investigate the relationships among a set of symptoms (fatigue, depression, impaired cognitive function, sleep disturbance) with pain severity and demographic variables. The sample of 40 women with relapsing-remitting multiple sclerosis completed instruments of pain, fatigue, depression, sleep disturbance, and an objective cognitive measure. Analysis identified one symptom cluster of pain, fatigue, depression, sleep disturbance, and impaired cognitive function, whereas a relationship between that symptom cluster and employment status existed. Pain severity correlated with fatigue, sleep disturbance, depression, and impaired cognitive function. Preliminary findings support providing education on symptoms to women with relapsing-remitting multiple sclerosis to ultimately guide their care.

What would you say? Expressing the difficulties of living with multiple sclerosis.

This article used a mixed method approach to analyze qualitative and quantitative responses from individuals with multiple sclerosis (MS) to determine differences when patients' perceived stress levels and perceived quality of support are taken into account. Understanding the differences in these responses can help us understand how illness, specifically MS, may influence the relational messages sent by patients to their loved ones. Responses to both quantitative and qualitative questions were obtained from 145 persons who have been diagnosed with MS. Participants responded to scale questions measuring daily stress levels and levels of social support and were divided into four groups on the basis of their scores (low/low, high/low, high/high, and high/low). Thematic analysis was performed on the qualitative responses, and differences were analyzed based on participants' grouping. Additional outcome variables measuring quality of life, anxiety, depression, helplessness, and acceptance were also analyzed to determine the similarities and differences between the groupings. The information presented in this article both informs and supports the idea that patients' levels of stress and perception of support are two major variables that impact their responses to their loved ones and their scores on several outcome variables.

Injectable disease-modifying therapy for relapsing-remitting multiple sclerosis: a review of adherence data.

Long-term adherence to disease-modifying therapy in relapsing-remitting multiple sclerosis (RRMS) is associated with improved patient outcomes, including a reduced risk of relapse and a better preserved quality of life. However, the unpredictable nature of the disease--even when it is being treated--may make it difficult to convince patients of the importance of treatment adherence. A number of studies have attempted to pinpoint factors that affect adherence. Nursing interventions that address some of these factors may improve adherence and, thus, the disease course for a variety of RRMS patients. This article summarizes literature that approximates the prevalence and impact of nonadherence and reviews factors identified in clinical trials that affect adherence. Nursing interventions that can improve adherence, including telephone counseling and motivational interview techniques, are also addressed.

Best practices in multiple sclerosis: infusion reactions versus hypersensitivity associated with biologic therapies.

Infusion nurses are uniquely positioned to play a vital role in the early identification and management of infusion and hypersensitivity reactions during the administration of biologic therapies. This article reviews the current evidence regarding reactions related to the administration of monoclonal antibodies, namely, natalizumab, a humanized monoclonal antibody against the cellular adhesion molecule alpha4-integrin, in patients with multiple sclerosis. In addition to differentiating between infusion and hypersensitivity reactions, the article presents general guidelines for the management of these reactions and provides case studies to better illustrate the use of appropriate interventions.

Pain in women with relapsing-remitting multiple sclerosis and in healthy women: a comparative study.

The purpose of this study was to examine multidimensional aspects of pain in women with relapsing-remitting multiple sclerosis (RRMS) and in healthy women. A cross-sectional, comparative design was used. The convenience sample included 40 women with RRMS and 40 healthy women. Participants completed the Brief Pain Inventory-Long Form and the McGill Pain Questionnaire-Short Form. The women with RRMS had a significantly higher presence of pain (p = .005), present pain intensity (p = .02), average pain intensity (p = .001), pain interference (p = .0008), and pain in different locations (p = .02) than healthy women. Pain has significant nursing implications for women with RRMS. Women with RRMS could benefit from a comprehensive pain assessment and management strategy. Nursing care should be designed to focus on interventions for minimizing and managing pain in women with RRMS.

Early interferon beta treatment in multiple sclerosis: nursing care implications of the BENEFIT study.

Interferon beta (IFNbeta) is a first-line treatment for relapsing forms of multiple sclerosis (MS) that can reduce the rate of clinical attacks and limit disability progression. Recent trials have shown that initiating IFNbeta treatment at the time of the first clinical event suggesting MS can delay the onset of clinically definite MS and, in the case of IFNbeta-1 b, inhibit the progression of later disability. These findings have led to a trend toward earlier treatment initiation in clinical practice. While trials show good levels of adherence to therapy, there often is room for improvement in the clinical setting. Managing MS symptoms and treatment-related adverse events and providing patient education are vital to optimize adherence, and nurses can employ a number of strategies as part of the support program to ensure patients gain the most benefit from their treatment. In addition to providing a great deal of evidence supporting early MS treatment, the ongoing BEtaseron in Newly Emerging multiple sclerosis For Initial Treatment (BENEFIT) study has highlighted the fact that IFNbeta can be well tolerated, especially with correct management. This article summarizes the lessons learned from the BENEFIT study, and the ways in which nurses can incorporate this knowledge into clinical practice.

The relationship between body image and depression in women diagnosed with relapsing remitting multiple sclerosis.

Little is known about perceptions of body image in women diagnosed with relapsing remitting multiple sclerosis (RRMS). This descriptive correlational study was conducted to describe how women perceive their body image while living with RRMS, and to examine a potential relationship between body image and depression in women who have RRMS. A convenience sample of 30 women from a western Canadian multiple sclerosis (MS) clinic completed a demographic questionnaire, the Body-Image Ideals Questionnaire (BIQ), and the Beck Depression Inventory Short Form (BDI-SF). Body image and depression scores were highly correlated (r = 0.814, p = 0.01) indicating that a more positive body image was associated with less depression. The findings of this study suggest that there are important psychological aspects to which clinicians might need to attend when working with women who have RRMS. However, further research needs to be done in this area.